Medical instruments are typically sterilized prior to use. Many methods are employed, including steam sterilization, hydrogen peroxide, vapor phase sterilization, either with or without a gas plasma and ethylene oxide (EtO). Each of these methods relates to a certain extent on the diffusion of fluid, primarily gaseous, sterilants into contact with the instruments and devices to be sterilized.
Typically, such instruments and devices are packaged within containers or pouches having a semi-permeable barrier, which allows transmission of the sterilizing fluid but prevents admission of contaminating organisms. Packaging of the instruments in this fashion creates a diffusion restriction somewhat inhibiting passage of the sterilizing fluid to the device or instrument. In addition, some devices and instruments have diffusion-restricted spaces therein; for example, endoscopes typically have long narrow lumen. The sterilizing fluid must diffuse into this long narrow lumen to effect sterilization therein. In addition to diffusion restrictions, the quantity of devices to be sterilized during one process, and the amount of absorbent material in proximity thereto all affect how the sterilizing fluid travels to and contacts the instruments to effect sterilization. A sufficient amount must remain in contact with the instrument for a sufficient period of time to achieve a desired level of sterilization.
To insure that proper sterilization has been achieved, it is typical to include some indicator of the sterilization process in proximity to the devices or instruments to be sterilized during the process. For instance, a biological indictor having a predetermined quantity of micro-organisms can be placed within a sterilization chamber if the device is to be sterilized and, after the process is complete, it can be cultured to determine whether any of the micro-organisms have survived. Biological indicators have evolved into designs in which a source of growth media in a frangible container is located adjacent to a quantity of micro-organisms and after the sterilization procedure is completed, the frangible container is broken to release the growth media and culture any remaining living organisms. Typically, color indication technology is included to show a color change in the presence of living organisms. Alternatively, an enzyme indicative of the organism viability may be detected. Examples of such devices are shown in U.S. Pat. Nos. 5,830,683 and 5,418,167, hereby incorporated by reference.
To more accurately replicate a challenge of diffusing a sterilant fluid into contact with the device during an actual sterilization procedure, it has sometimes been the practice to place a biological indicator inside of a challenge device having a diffusion restriction, such as a long tortuous path. U.S. Pat. Nos. 5,895,627 and 5,872,004 illustrate examples of such challenge devices, and are incorporated herein by reference.